{"filing":{"accession_number":"0001517022-26-000047","cik":"0001517022","ticker":"AKBA","company_name":"Akebia Therapeutics, Inc.","form":"8-K","filing_date":"2026-06-30","report_date":null,"primary_document":"akba-20260630.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1517022/000151702226000047/akba-20260630.htm"},"events":[{"id":14851,"run_id":13239,"accession_number":"0001517022-26-000047","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Akebia announced positive interim analysis results from the VOICE trial demonstrating that Vafseo (vadadustat) met predefined stopping criteria by establishing non-inferiority and superiority on the primary composite endpoint of mortality and hospitalization, with a statistically significant reduction in hospitalizations versus standard-of-care ESA. This represents a material clinical milestone for the company's marketed product, providing significant positive clinical evidence supporting the commercial viability and differentiation of Vafseo in the dialysis anemia market.","company_name":"Akebia Therapeutics, Inc.","ticker":"AKBA","filing_date":"2026-06-30","form":"8-K","submitted_at":null,"items":[{"id":12412,"accession_number":"0001517022-26-000047","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces positive interim analysis results from the VOICE trial showing that Vafseo (vadadustat) met predefined stopping criteria by establishing non-inferiority and superiority on the primary composite endpoint of mortality and hospitalization. This is a material clinical trial milestone for Akebia's marketed product, demonstrating improved safety outcomes versus standard-of-care ESA. While the event is operational/clinical in nature rather than financial or governance, it is material to investors as it provides significant positive clinical evidence supporting the commercial viability and differentiation of Vafseo in the dialysis anemia market.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-30T12:05:45.347579+00:00","company_name":"","ticker":null,"filing_date":""},{"id":12413,"accession_number":"0001517022-26-000047","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces positive interim trial results for Vafseo (vadadustat) in the VOICE trial, demonstrating non-inferiority and superiority on the primary composite endpoint of mortality and hospitalization (win odds 1.16, p=0.0016), with a statistically significant reduction in hospitalizations. This is a material clinical milestone for an approved product, but does not fit the earnings_release category (no financial results) or other specific event types. The trial's early stopping based on prespecified criteria represents a significant operational and strategic development for the company's marketed product, making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-30T12:05:45.347579+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":12412,"accession_number":"0001517022-26-000047","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces positive interim analysis results from the VOICE trial showing that Vafseo (vadadustat) met predefined stopping criteria by establishing non-inferiority and superiority on the primary composite endpoint of mortality and hospitalization. This is a material clinical trial milestone for Akebia's marketed product, demonstrating improved safety outcomes versus standard-of-care ESA. While the event is operational/clinical in nature rather than financial or governance, it is material to investors as it provides significant positive clinical evidence supporting the commercial viability and differentiation of Vafseo in the dialysis anemia market.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-30T12:05:45.347579+00:00","company_name":"Akebia Therapeutics, Inc.","ticker":"AKBA","filing_date":"2026-06-30"},{"id":12413,"accession_number":"0001517022-26-000047","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces positive interim trial results for Vafseo (vadadustat) in the VOICE trial, demonstrating non-inferiority and superiority on the primary composite endpoint of mortality and hospitalization (win odds 1.16, p=0.0016), with a statistically significant reduction in hospitalizations. This is a material clinical milestone for an approved product, but does not fit the earnings_release category (no financial results) or other specific event types. The trial's early stopping based on prespecified criteria represents a significant operational and strategic development for the company's marketed product, making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-30T12:05:45.347579+00:00","company_name":"Akebia Therapeutics, Inc.","ticker":"AKBA","filing_date":"2026-06-30"}]}